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PF-04895162

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Mar 28, 2013

PF-04895162 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

PF-04895162 clinical trials

PF-04895162 · 1 trial · 1 indication

Phase 1 1
NCT01691274A Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Multiple Oral Doses Of PF-04895162Healthy
COMPLETED10 Analytics
PHASE1COMPLETED
A Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Multiple Oral Doses Of PF-04895162
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum observed plasma concentration (Cmax)
up to 12 h post dose for Days 1, 7 and 14
Time of maximum concentration (Tmax)
up to 12 h post dose for Days 1, 7 and 14
Area under the plasma concentration time profile from time zero extrapolated to inifinite time (AUCinf)
up to 12 h post dose for Days 1, 7 and 14
Area under the plasma concentration time profile from time zero to the time of last quantifiable concentration (AUClast)
up to 12 h post dose for Days 1, 7 and 14
Area under the plasma concentration time profile from time zero to quantifiable concentration 24 h post dose (AUC24)
up to 12 h post dose for Days 1, 7 and 14
AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL)
up to 12 h post dose for Days 1, 7 and 14
t1/2 = Terminal Elimination half life
up to 12 h post dose for Days 1, 7 and 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PF-04895162EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-04895162DRUGTablets, 300 mg, single, 1 day
PlaceboDRUGTablets, twice a day, 14 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy male and/or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and puls...

Countries:United States
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Frequently asked questions about PF-04895162

What is PF-04895162?

PF-04895162 is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE). It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease or condition it is intended to treat has not been disclosed, and it remains in early clinical development.

Who is developing PF-04895162?

PF-04895162 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 study of the compound conducted in the United States.

What phase is PF-04895162 in?

PF-04895162 is in Phase 1 clinical development. It has completed one Phase 1 trial, and no active trials are currently listed. The compound has not been approved by the FDA and remains investigational.

What clinical trials is PF-04895162 in?

PF-04895162 has been evaluated in one completed Phase 1 trial, NCT01691274, titled "A Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Multiple Oral Doses Of PF-04895162." The trial enrolled 10 healthy adult volunteers in the United States and was randomized, double-blind, and placebo-controlled.

Is PF-04895162 FDA approved?

No. PF-04895162 is an investigational drug and has not been approved by the FDA. It has completed only a single Phase 1 trial involving 10 healthy volunteers, so it remains in early clinical development.